A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream

NCT06213831 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB18424-110
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 20

Brief Summary

This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).

Conditions

Prurigo Nodularis

Keywords

Prurigo Nodularis; PN; ruxolitinib

Outcome Measures

Primary Outcomes (2)

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

  Up to 16 weeks, including 30 days of safety follow-up

• Number of participants with TEAEs leading to dose interruption or discontinuation

  Number of participants with TEAEs leading to dose interruption or discontinuation.

  Up to 16 weeks, including 30 days of safety follow-up

Secondary Outcomes (1)

• Ruxolitinib pharmacokinetic (PK) parameters in plasma

  Up to 16 weeks, including 30 days of safety follow-up

Study Arms (1)

Maximal Use Ruxolitinib 1.5%

EXPERIMENTAL

Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions.

Drug: Ruxolitinib Cream 1.5%

Interventions

Ruxolitinib Cream 1.5% DRUG

Ruxolitinib Cream 1.5%

Maximal Use Ruxolitinib 1.5%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of PN ≥ 3 months before screening.
• Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
• Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
• IGA-CPG-S score of ≥ 2 at screening and baseline.
• Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).

You may not qualify if:

• Chronic or acute pruritus due to a condition other than PN.
• Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
• Acute or chronic active HBV or HCV infection.
• Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
• Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (20)

Saguaro Dermatology

Phoenix, Arizona, 85008, United States

Location

Affiliated Dermatology

Scottsdale, Arizona, 85255, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Amicis Research Center Valencia

Northridge, California, 91324, United States

Location

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, 90404, United States

Location

Advanced Pharma Cr, Llc

Miami, Florida, 33147, United States

Location

Sullivan Dermatology North Miami Beach Office

North Miami Beach, Florida, 33162, United States

Location

Olympian Clinical Research

Tampa, Florida, 33615, United States

Location

St Lukes Clinic Dermatology Ketchum

Ketchum, Idaho, 83340, United States

Location

Dawes Fretzin Clinical Research Group Llc

Indianapolis, Indiana, 46250, United States

Location

Equity Medical

Bowling Green, Kentucky, 42104, United States

Location

Oakland Hills Dermatology Pc

Auburn Hills, Michigan, 48326, United States

Location

Revival Research Institute, Llc Troy

Troy, Michigan, 48084, United States

Location

Equity Medical, Llc

New York, New York, 10023, United States

Location

Red River Research Partners

Fargo, North Dakota, 58103, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73170, United States

Location

Paddington Testing Co Inc

Philadelphia, Pennsylvania, 19103, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Dermresearch, Inc.

Austin, Texas, 78759, United States

Location

North Texas Center For Clinical Research Ntccr

Frisco, Texas, 75034, United States

Location

Related Links

• A study to evaluate the safety and tolerability of maximal use Ruxolitinib Cream

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: February 27, 2024
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)